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A longitudinal assessment of trial protocols approved by research ethics committees: the Adherance to SPIrit REcommendations in the UK (ASPIRE-UK) study

Abstract:

Background
To assess the quality of reporting of RCT protocols approved by UK research ethics committees before and after the publication of the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guideline.

Methods
We had access to RCT study protocols that received ethical approval in the UK in 2012 (n=103) and 2016 (n=108). From those, we assessed the adherence to the 33 SPIRIT items (i.e. a total of 64 components...

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Publication status:
Published
Peer review status:
Peer reviewed

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Publisher copy:
10.1186/s13063-022-06516-1

Authors


More by this author
Institution:
University of Oxford
Division:
MSD
Department:
NDORMS
Role:
Author
ORCID:
0000-0002-3301-8085
More by this author
Institution:
University of Oxford
Role:
Author
More by this author
Institution:
University of Oxford
Division:
MSD
Department:
NDORMS
Sub department:
Botnar Research Centre
Role:
Author
ORCID:
0000-0003-1066-0726
More by this author
Institution:
University of Oxford
Division:
MSD
Department:
NDORMS
Sub department:
Botnar Research Centre
Role:
Author
ORCID:
0000-0003-1877-8323
More by this author
Institution:
University of Oxford
Role:
Author
More from this funder
Name:
Swiss National Science Foundation
Publisher:
BioMed Central
Journal:
Trials More from this journal
Volume:
23
Issue:
1
Article number:
601
Publication date:
2022-07-27
Acceptance date:
2022-07-05
DOI:
EISSN:
1745-6215
Pmid:
35897110
Language:
English
Keywords:
Pubs id:
1272604
Local pid:
pubs:1272604
Deposit date:
2022-12-06

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